FDA 510(k) Neurology Devices
FDA 510(k) Neurology Devices - Regulatory Overview
FDA 510(k) neurology devices cover diagnostic and therapeutic equipment for the nervous system. The FDA review panel code is NE.
Common categories include:
- EEG and neurophysiology systems - electroencephalographs, EMG, nerve conduction
- Neurostimulators - transcranial magnetic stimulation (TMS), vagus nerve stimulation
- Surgical navigation systems - image-guided neurosurgery platforms
- Intracranial pressure monitors - ICP sensors and drainage systems
- Neuroendoscopes - rigid and flexible scopes for minimally invasive neurosurgery
6291
Total
6236
Cleared
153d
Avg (2y)
1976
Since
4701 Neurology devices
Cleared
Dec 23, 2020
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
GXH
Device, Surgical, Cryogenic
281d
Cleared
Dec 23, 2020
Scrambler Therapy Technology (Model ST-5A)
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
205d
Cleared
Dec 22, 2020
EZTrack
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
166d
Cleared
Dec 22, 2020
actiTENS
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
141d
Cleared
Dec 22, 2020
Everyway Analog OTC TENS, model N103A/N302
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
85d
Cleared
Dec 22, 2020
COOLIEF Cooled Radiofrequency Kit Advanced
GXI
Probe, Radiofrequency Lesion
74d
Cleared
Dec 16, 2020
Longeviti ClearFit Cranial Implant
GXN
Plate, Cranioplasty, Preformed, Non-alterable
33d
Cleared
Dec 14, 2020
Columbus Guidewire
MOF
Guide, Wire, Catheter, Neurovasculature
304d
Cleared
Dec 10, 2020
Neuronaute
GWQ
Full-montage Standard Electroencephalograph
115d
Cleared
Dec 07, 2020
BNA Platform
OLU
Normalizing Quantitative Electroencephalograph Software
90d
Cleared
Nov 27, 2020
Axonpen, Axonmonitor, Axonbox, Tablet
GWG
Endoscope, Neurological
196d
Cleared
Nov 25, 2020
DR-HO'S Electro Therapy Conductive Gel
GYB
Media, Electroconductive
280d
Cleared
Nov 25, 2020
Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
89d
Cleared
Nov 20, 2020
Codman Surgical Patties & Strips
HBA
Neurosurgical Paddie
353d
Cleared
Nov 20, 2020
Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
333d
Cleared
Nov 20, 2020
NeuroStar Advanced Therapy
OBP
Transcranial Magnetic Stimulator
204d
Cleared
Nov 16, 2020
Avid CT2
IPF
Stimulator, Muscle, Powered
77d
Cleared
Nov 13, 2020
Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
88d
Cleared
Nov 11, 2020
Route 92 Medical 070 Access System
QJP
Catheter, Percutaneous, Neurovasculature
36d
Cleared
Nov 09, 2020
OGYILI TENS/NMES Stimulator
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
161d
Cleared
Nov 09, 2020
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
90d
Not Cleared
Nov 06, 2020
NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable
QMZ
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
163d
Cleared
Nov 04, 2020
Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
GWG
Endoscope, Neurological
125d
Cleared
Oct 30, 2020
Longeviti ClearFit Cranial Implant
GXN
Plate, Cranioplasty, Preformed, Non-alterable
31d
Cleared
Oct 29, 2020
Sleepware G3
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
90d
Looking for a specific neurology device? Search by device name, K-number or manufacturer.
Search all Neurology 510(k) devices